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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
| British Columbia Cancer Agency | OTHER |
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A feasibility study to determine the appropriateness of yoga intervention to improve health-related quality of life in adult cancer patients.
A prospective, mixed methods feasibility trial allocated participants to receive one of three yoga interventions over a four-week study period. Data collection was completed through online survey of QOL-CA/CS and customized surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga Group A: Minimum Exposure | Experimental | The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. In Week 1, this session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class. |
|
| Yoga Group B: Medium Exposure | Experimental | The medium-exposure yoga package, this intervention included the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in Week 1. Participants were then invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study (Weeks 1 to 4). In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during Week 2 or 3. |
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| Yoga Group C: Maximum Exposure | Experimental | The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in Week 1. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study (Weeks 1 to 4). Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (Weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Other | A mind-body therapy that includes specified breathing, meditation and physical postures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Patient Recruitment to Yoga Intervention | Number of participants eligible for randomization to yoga intervention during cancer treatment | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Adherence to Yoga Intervention | Number of participants who completed their yoga intervention | 6 weeks |
| Patient Adherence Rate to Yoga Intervention | % of patients who completed their yoga intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptability of Yoga Intervention | Amount of satisfaction for adult cancer patients assessed via Likert-scale surveys; on scale of 1 to 10, 1 being not satisfied; 10 being extremely satisfied (i.e higher number, better outcome). | 6 weeks |
| Financial Cost of Delivering Yoga Intervention in a Clinical Setting |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie McDonald, MSW | Vancouver-BCCA | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26170884 | Derived | McCall M, McDonald M, Thorne S, Ward A, Heneghan C. Yoga for Health-Related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:816820. doi: 10.1155/2015/816820. Epub 2015 Jun 11. |
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No wash out or run-in period was allocated.
Recruitment ended on June 30, 2014 and participants were randomized on July 1, 2014.
Recruitment in Vancouver, Canada commenced on April 15, 2014 via poster advertisements in Vancouver cancer clinics (n=3).
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| ID | Title | Description |
|---|---|---|
| FG000 | Yoga Group A | The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. |
| FG001 | Yoga Group B | The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. |
| FG002 | Yoga Group C | The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The sample includes male and female (n=11) adult cancer patients receiving conventional treatment in Vancouver, Canada.
Patients undergoing one or more treatments of chemotherapy, radiation, hormone therapy or active surveillance were included in the study. Baseline data collection included all types of treatment for a primary cancer diagnosis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Yoga Group A: Minimum Exposure | The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Patient Recruitment to Yoga Intervention | Number of participants eligible for randomization to yoga intervention during cancer treatment | Male (n=4) and female (n=11) adult patients undergoing conventional treatment in Vancouver, Canada for a cancer diagnosis; who have not participated in yoga the past month. | Posted | Number | participants | 10 weeks |
|
|
4 weeks
Self-reported injury or pain related to the yoga intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga Group A | The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. |
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As a feasibility study, the sample size is underpowered and quantitative results are unreliable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcy McCall, Lead Researcher | University of Oxford | +441865 289300 | marcy.mccall@kellogg.ox.ac.uk |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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|
| 6 weeks |
Calculation of the per participant cost of three types of yoga interventions (Group A, B and C). The financial data included cost of in-person instruction, cost of materials and time to design and implement intervention per participant in each yoga group. |
| 10 weeks |
| Patient's Health-related Quality of Life | Assessed via an online survey of a validated, cancer-specific survey instrument measuring health-related quality of life (QOL-CA/CS), (0 worst; 10 best possible). The QOL-CA/CS score was assessed pre and post yoga intervention. | 6 weeks |
| BG001 | Yoga Group B: Medium Exposure | The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. |
| BG002 | Yoga Group C: Maximum Exposure | The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Tumour Location | Number | participants |
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| Stage of Cancer Diagnosis | Number | participants |
|
| Types of Conventional Treatment | Participants were asked to self-report any and all aspects of current conventional treatments for their cancer diagnosis; multiple treatments were recorded (i.e. radiotherapy, chemotherapy, hormone therapy or active surveillance) | Number | participants |
|
|
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| Secondary | Patient Adherence to Yoga Intervention | Number of participants who completed their yoga intervention | Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada | Posted | Number | participants | 6 weeks |
|
|
|
| Other Pre-specified | Patient Acceptability of Yoga Intervention | Amount of satisfaction for adult cancer patients assessed via Likert-scale surveys; on scale of 1 to 10, 1 being not satisfied; 10 being extremely satisfied (i.e higher number, better outcome). | Adult male (n=3) and female (n=9) cancer patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada | Posted | Mean | Full Range | units on satisfaction scale | 6 weeks |
|
|
|
| Other Pre-specified | Financial Cost of Delivering Yoga Intervention in a Clinical Setting | Calculation of the per participant cost of three types of yoga interventions (Group A, B and C). The financial data included cost of in-person instruction, cost of materials and time to design and implement intervention per participant in each yoga group. | Male (n=3) and female (n=10) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada | Posted | Number | dollars (USD) | 10 weeks |
|
|
|
| Other Pre-specified | Patient's Health-related Quality of Life | Assessed via an online survey of a validated, cancer-specific survey instrument measuring health-related quality of life (QOL-CA/CS), (0 worst; 10 best possible). The QOL-CA/CS score was assessed pre and post yoga intervention. | Male (n=3) and female (n=9) adults undergoing conventional treatment for cancer diagnosis in Vancouver, Canada. | Posted | Mean | Full Range | units on quality of life scale | 6 weeks |
|
|
|
| Secondary | Patient Adherence Rate to Yoga Intervention | % of patients who completed their yoga intervention | Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada | Posted | Number | percentage of participants | 6 weeks |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Yoga Group B | The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. | 0 | 5 | 0 | 5 |
| EG002 | Yoga Group C | The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient. Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures. | 0 | 4 | 0 | 4 |
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| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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| Mean Difference |
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